Module 1: Legislation Flashcards
Describe and present which national and EU laws and guidance which regulate the scientific use of animals and in particular the activities of those carrying out scientific procedures involving them, as well as other forms of relevant animal welfare legislation, and discuss how to find the relevant legislation.
EU directive 2010/63/EU: authorizes animal experiments, mandates ethical review,
imposes requirements for the of use of animals, encourages the use of alternatives &
ensures the humane treatment and euthanasia of animals.
–> all EU members must follow these rules
National laws in Denmark
o Animal Experimentation Act
▪ overrules animal welfare act & governs the use of animals for
scientific purposes in Denmark.
▪ aligns with EU Directive to ensure high standards of animal welfare
▪ activities: ethical reviewing, compliance with 3Rs, sets standards for
care, housing & treatment & grants Animal Experiments
Inspectorate the authority to conduct inspections to ensure compliance
with regulations
o Animal Experimentation Oder gives more detailed descriptions of the rules
of the Animal Experimentation act
* Animal Experimentation Inspectorate gives licenses & monitors the compliance
with laws
* animal welfare bodies advices people on 3Rs, culture of care & legal requirements
* relevant legislations can be found on respective websites
This means, that all contries in the European Union have the same legislation, but in some individual contries they might be stricter in some ways, e.g., in the UK no animals can be used for educational purpose, in DK intensive suffering or intensive fear are not allowed in lab animals, and in Sweeden there is no lower limit.
Describe the authorisation that is needed before acting as user, breeder or supplier of laboratory animals and especially the authorisation required for projects and where applicable individuals. Describe who will grant you a license in Denmark, how this authority is organized, and which other functions this authority has.
- requirements for authorization:
o Individuals performing experiments must obtain a personal license
o institution where the experiments are conducted must also be licensed. This
includes having appropriate facilities & equipment to meet welfare standards. - project license
o any scientific project involving animals must be individually licensed
o A detailed project proposal must be submitted, including objectives, methods,
species and number of animals, and justification for animal use.
o proposal undergoes an ethical review to assess compliance with the 3Rs & to
evaluate potential benefits vs. harms to the animal - Animal Experiments Inspectorate oversees authorization process. They ensure that
all activities comply with legal requirements & ethical standards and they conduct
regular inspections
Describe the roles and responsibilities of the local animal welfare bodies and the national committee for the protection of animals used for scientific purposes.
Local:
* focus on ensuring the humane treatment & well-being of animals at each institution
* have now legal say: can’t prohibit experiments
* activities: advise the staff on animal welfare, the 3R’s , Culture of care, technical and scientific developments, provide policy advises, run campaigns to educate
* members: veterinarians, legal experts, scientists, doctors, animal technicians, facility management, external members, professors
National Committee for Experimental Animals and Alternatives
- advise the competent authorities & animal welfare bodies regarding use of animals in research
Describe who is responsible for compliance in relation how the experiment is performed, and how the animals are housed in the facility. Describe what is expected from the scientist in relation to being aware of local organisation of animal work.
- Animal experimentation officer/ manager + vetenarian
- expectations from scientists
o You as a license holder are responsible for the correct performance of the procedure & animal welfare
—> need to make sure that people working for you are qualified
—> in reality the manager looks after the animal welfare part
o adhere to the project plans approved by the Animal Experiment Inspectorate
o follow SOPs for conducting experiments
o consider the 3 Rs
o Engage with ethical review committees
Describe minimum and maximum threshold of pain, suffering, distress or lasting harm, i.e. when a procedure becomes regulated as an animal experiment, and when it cannot be allowed no matter the purpose.
Min:
The injection criterion: a procedure must be licensed if it causes pain, suffering, distress, or lasting harm equivalent to or higher than that caused by the introduction of needle in accordance with good veterinary practice
Max:
Strong pain, other forms of intensive suffering or intensive fear
Never allowed: Procedures causing extreme suffering or pain without potential relief, like extensive
surgery without anesthesia are prohibited, independent from potential benefits
What is meant by destinational breeding in relation animal experimentation legislation, and give examples of some species covered and some species not covered.
- destination breeding = method where lab animals are bred specifically to meet the requirements of a facility, ensuring they arrive at the precise age or developmental stage needed for experiments.
- optimizes timing, improves animal welfare, and enhances research consistency.
- covered species: mice, rats, zebrafish
- not covered: domestic cats & dogs, wildlife
Indicate the circumstances in which animals under the scope of the Directive should be humanely killed or removed from the study to receive veterinary treatment, and describe the legislative controls over the killing of animals bred or used for scientific procedures.
If the animal does experience strong pain, intensive suffering or intensive fear, termination is necessary.
Annex four of EU directive:
- table of acceptable and unacceptable methods for euthanasia
- also makes clear that other methods may only be used on unconscious animals not regaining consciousness before death or agricultural research animals if required if required that these are kept under similar conditions to commercial farm animals and in accordance with their EU regulation
- after the killing: death must be ensured by 1) confirmation of permanent cessation of the circulation, 2) destruction of the brain, 3) dislocation of the neck, 4) exsanguination or 5) confirmation of the onset of rigor mortis
Describe how the animal experimentation act is based on an ethical framework which requires 1) weighing the harms and benefits of projects (the harm/benefit assessment) 2) applying the Three Rs to minimise the harm, maximise benefits and 3) promote good animal welfare practices.
- Animal Experimentation Act is based on an ethical framework that emphasizes the following principles:
- Harm/Benefit Assessment: projects must undergo an ethical review where the potential harms to the animals are weighed against the expected scientific or societal benefits. Approval is granted only if the benefits justify the harms.
- The Three Rs: replacement, reduction & refinement
- Promotion of Good Animal Welfare Practices
o Care Standards: Ensures that animals are housed, cared for, and treated according to high welfare standards throughout their lives.
o Continuous Improvement: Encourages ongoing efforts to improve practices and implement the latest advances in animal care and welfare.
- Promotion of Good Animal Welfare Practices
Describe the severity classification system, and give examples of each category. Describe cumulative severity and the effect this may have on the severity classification.
- European Directive 2010/63/EU outlines 4 severity classifications to categorize the impact of procedures on animal welfare: non-Recovery, mild, moderate & severe
- Non-Recovery
o procedures under general anesthesia without regaining consciousness.
o Examples: terminal surgeries to harvest organs
- Non-Recovery
- Mild
o procedures that cause short-term mild pain, suffering, distress, or lasting harm. Animals are expected to return to their normal state quickly.
o Examples: superficial biopsies, short-term social isolation & gavaging
- Mild
- Moderate
o procedures that cause short-term moderate pain, suffering, distress, or lasting harm, or long-lasting mild pain, suffering, or distress.
o Examples: moderate disease models like diabetes models
- Moderate
- Severe
o procedures that cause severe pain, suffering, distress, or lasting harm.
o E.g.,:I nduction of severe disease models with high morbidity and mortality rates, like certain cancer or infectious disease models.
- Severe
- Cumulative severity = overall impact of multiple procedures or repeated interventions on an animal over time.
–> e.g.; repeated blood sampling, chronic disease models & multiple surgeries
Describe the regulations regarding re-use of animals.
Each case of re-use must be approved by the Animal Experiment Inspectorate
* Animals must be in good health & have fully recovered from previous procedures.
* permitted only if the cumulative severity of procedures doesn’t exceed moderate
levels of pain, suffering, or distress.
* There must be a strong scientific justification rather than using a new one
Describe the four functions in relation to educational demands for staff involved in animal experimentation, as well as the role of the manager (EU article 24) and the designated vet (EU article 25).
- 4 educational demands for staff
o training/ competency: Staff must receive comprehensive training to acquire the necessary skills and knowledge for handling animals
o ethical & legal compliance: Staff must be educated on ethical considerations, animal welfare laws, and institutional policies
o health & safety: understand zoonotic disease prevention, proper use of personal protective equipment (PPE) & safe handling of hazardous materials
o data integrity: Staff must be trained in accurate data collection & record-keeping to ensure the reliability and reproducibility of experimental results - Role of the Manager (EU Article 24):
o oversee implementation of educational programs & assess staff competence - Role of the designated veterinarian (EU Article 25):
o responsible for the health and welfare of animals used in experiments.
o provide guidance & training on animal care, monitor animal health & advise on appropriate treatment and euthanasia when necessary.
